Senior Quality Improver-Costa Rica
CooperVision
Alajuela, Costa Rica
hace 4 días

JOB SUMMARY

Performs and / or coordinates specific tasks and functions within the company’s Quality System areas.

ESSENTIAL FUNCTION

  • Material quality issues avoidance.
  • Evaluate quality issues reports in Manufacturing, Quality Assurance Final Inspection and Quality Assurance Laboratories.
  • Investigate Non-Conforming Reports (NCR), laboratory investigations and complaints.
  • Prepare rework protocols for NCRs.
  • Monitors & measures Quality Key Performance Indicators (KPI).
  • Lead quality improvements projects
  • Lead CAPA / PA investigation for Quality System issues & improvement.
  • Support to sterilization process requirements, validation, and parametric release parameters.
  • Monitors to assure compliance and strengthening of Sterilization Program.
  • Develops procedures for quality.
  • Assures compliance with laws & regulations.
  • Develops & executes engineering studies for new processes / new technology.
  • Systems & equipment PM’s SOP’s revisions / improvements.
  • POSITION QUALIFICATION

    KNOWLEDGE, SKILLS AND ABILITIES

  • Five years or more of experience in Quality Engineering.
  • Knowledge of Quality System Regulations, FDA, and ISO, MDSAP, etc.
  • Excellent oral and written communication skills in both English and Spanish.
  • Strong experience in Microbiology concepts (i.e. spores, Bioburden, aseptic techniques, contamination control,
  • etc.) Desirable

  • Knowledge in Steam Sterilization process (autoclave) Desirable
  • Strong applied knowledge on statistical tools : DOE, Acceptance Sampling, SPC, etc.
  • Computer skills (i.e. excel, word, power point, etc ).
  • Problem solving & continuous improvement skills
  • Lean Manufacturing knowledge ( desirable)
  • Willing to Travel
  • WORK ENVIRONMENT

  • Generally works in a closed environment, in office conditions, with loud level of noise and controllable changes of temperature.
  • Needs to stand, walk and may be seated for some period of time.
  • Could be required to travel.
  • Works with a personal computer and programs to prepare documents or reports.
  • Applies communication skills (good reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others.
  • Needs to have analytical capacity and level of professionalism and judgment to resolve problems.
  • EDUCATION

  • Bachelor degree in Science with major in Industrial Engineering, Electric or Electronic Engineer
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